EXCELLENT JOB BY THE ITA!!! - tanTALK

Robert K · 08-06-2013, 11:37 AM

Indoor Tanning Association, Inc., 2025 M St, NW Suite 800 Washington, DC 20036 · Phone: 888-377-0477 · Fax: 202-367-2142

Member Update 08/06/2013:

ITA Files Extensive Comments on the FDA’s Proposed Order to Reclassify Ultraviolet Lamps for Tanning

Yesterday the ITA filed detailed comments on behalf of the indoor tanning industry urging the FDA to reconsider its proposed order to reclassify sunlamp products as class II medical devices, go back to the drawing boards and start again on this vitally important issue for this industry.
Our comments focused on four specific points:
1. "sunlamp products” are not medical devices but instead are electronic products;
2. the proposed reclassification order is contrary to law because FDA has not satisfied the statutorily specified criteria and procedures;
3. duplicative controls under 21 C.F.R. §878.4635 and 21 C.F.R. §1040.20 contravene the statute’s "least burdensome” requirement; and
4. There is questionable scientific support to proceed with finalizing the order.
Click here to read the full text of the ITA’s comments.
In addition, because the proposed order most immediately affects the manufacturers of sunlamps, the ITA submitted supplemental comments for seven ITA members who manufacturer sunlamps. The supplemental comments focused on failures in the proposed order.
We pointed out to the FDA that the proposed order fails to:
1. differentiate between UV lamps and other indoor tanning equipment and the requirements applicable to each;
2. address which requirements will apply to UV lamps already in the market; and
3. Disclose all of the requirements that will be imposed under the order, if finalized.
Click here to read the full text of the ITA’s supplemental comments for UV lamp manufacturers.
In addition, as an attachment to the ITA comments, we submitted two documents that are also referenced in our comments. The first is titled "Tanning Bed Literature Critique”. This paper reviews the five additional new studies listed in the FDA’s proposed order as part of the justification for its release.Click Here.
Literature review originally filed in 2010 but never addressed by the FDA. (See attached 9-13-10 fda literature review to FDA) Click here.
Tomorrow is the deadline for comments. Over 2000 have been filed already. If you have not done so, please file your comments before the deadline.

parrot head · 08-19-2013, 07:52 AM

When does the FDA meet?

agapeachgurl · 08-22-2013, 10:54 AM

When will they make there final decision ?

Robert K · 08-22-2013, 11:19 AM

It may be by the end of the year or it may take years.

personalloansg · 09-18-2013, 03:12 AM

Perfect ITA. Thanks for the update.

08-06-2013, 11:37 AM	#1 (permalink)
Robert K Team TanTalk Join Date: Aug 27 2002 Location: East Coast Age: 56 Posts: 2,888 Rep Power: 22	EXCELLENT JOB BY THE ITA!!! Indoor Tanning Association, Inc., 2025 M St, NW Suite 800 Washington, DC 20036 · Phone: 888-377-0477 · Fax: 202-367-2142 Member Update 08/06/2013: ITA Files Extensive Comments on the FDA’s Proposed Order to Reclassify Ultraviolet Lamps for Tanning Yesterday the ITA filed detailed comments on behalf of the indoor tanning industry urging the FDA to reconsider its proposed order to reclassify sunlamp products as class II medical devices, go back to the drawing boards and start again on this vitally important issue for this industry. Our comments focused on four specific points: 1. "sunlamp products” are not medical devices but instead are electronic products; 2. the proposed reclassification order is contrary to law because FDA has not satisfied the statutorily specified criteria and procedures; 3. duplicative controls under 21 C.F.R. §878.4635 and 21 C.F.R. §1040.20 contravene the statute’s "least burdensome” requirement; and 4. There is questionable scientific support to proceed with finalizing the order. Click here to read the full text of the ITA’s comments. In addition, because the proposed order most immediately affects the manufacturers of sunlamps, the ITA submitted supplemental comments for seven ITA members who manufacturer sunlamps. The supplemental comments focused on failures in the proposed order. We pointed out to the FDA that the proposed order fails to: 1. differentiate between UV lamps and other indoor tanning equipment and the requirements applicable to each; 2. address which requirements will apply to UV lamps already in the market; and 3. Disclose all of the requirements that will be imposed under the order, if finalized. Click here to read the full text of the ITA’s supplemental comments for UV lamp manufacturers. In addition, as an attachment to the ITA comments, we submitted two documents that are also referenced in our comments. The first is titled "Tanning Bed Literature Critique”. This paper reviews the five additional new studies listed in the FDA’s proposed order as part of the justification for its release.Click Here. Literature review originally filed in 2010 but never addressed by the FDA. (See attached 9-13-10 fda literature review to FDA) Click here. Tomorrow is the deadline for comments. Over 2000 have been filed already. If you have not done so, please file your comments before the deadline. __________________ Robert Klem Superior UV Technologies (888) 526-7712 x77 robertk@superioruv.com

08-19-2013, 07:52 AM	#2 (permalink)
parrot head Team TanTalk Join Date: Jul 13 2004 Location: Menomonie, Wi. Age: 82 Posts: 3,145 Rep Power: 22	Re: EXCELLENT JOB BY THE ITA!!! When does the FDA meet?

08-22-2013, 10:54 AM	#3 (permalink)
agapeachgurl Join Date: Jun 25 2007 Posts: 12 Rep Power: 0	Re: EXCELLENT JOB BY THE ITA!!! When will they make there final decision ?

08-22-2013, 11:19 AM	#4 (permalink)
Robert K Team TanTalk Join Date: Aug 27 2002 Location: East Coast Age: 56 Posts: 2,888 Rep Power: 22	Re: EXCELLENT JOB BY THE ITA!!! It may be by the end of the year or it may take years. __________________ Robert Klem Superior UV Technologies (888) 526-7712 x77 robertk@superioruv.com

09-18-2013, 03:12 AM	#5 (permalink)
personalloansg I'm Banned Join Date: Sep 18 2013 Location: personalloansg Posts: 1 Rep Power: 0	Re: EXCELLENT JOB BY THE ITA!!! Perfect ITA. Thanks for the update.

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